FDA to implement stricter vaccine rules after memo ties child deaths to COVID-19 vaccine

The U.S. Food and Drug Administration is preparing to implement stricter guidelines for vaccine approvals after an internal memo claims at least ten children died “after and because of” receiving the COVID-19 vaccine. 

The guidelines, which were obtained by the New York Times, could impact other vaccinations, including by limiting shots for pregnant women and requiring larger studies before vaccine approvals. 

The Director of FDA’s vaccine division, Dr. Vinay Prasad, reportedly sent the memo to staff on Friday explaining that a review had found that the ten children had died due to complications related to myocarditis, or inflammation of the heart muscle, the New York Times reported. 

“This is a profound revelation,” Dr. Prasad reportedly wrote in the memo. “For the first time, the U.S. F.D.A. will acknowledge that Covid-19 vaccines have killed American children.”

The memo, which has not been publicly released, did not provide any details about the review or how the agency determined the links between the deaths and COVID-19 vaccines.  

Department of Health and Human Services Secretary Robert Kennedy Jr. has already issued new policies geared toward limiting access to COVID-19 vaccinations to people 65 and older and younger people with underlying health conditions. 

In the memo, which was also obtained by The Washington Post, Dr. Prasad also told staff that the review would likely prompt the agency to rethink its guidelines for annual flu shots, to determine if it is safe for Americans to receive multiple vaccines at once, and require vaccine makers to provide more data showing products are safe and effective.